Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.
Legislation related to this standard
WITHDRAWN
EN 60601-1-4:1996
99.60
Withdrawal effective
Dec 31, 2018
WITHDRAWN
EN 60601-1-4:1996/A1:1999
PUBLISHED
EN 60601-1:2006